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Background Programme evaluations conducted alongside randomised controlled trials (RCTs) have potential to enhance understanding of trial outcomes. This paper describes a multi-level programme evaluation to be conducted alongside an RCT of a falls prevention programme (RESPOND). Objectives (1) To conduct a process evaluation in order to identify the degree of implementation fidelity and associated barriers and facilitators. (2) To evaluate the primary intended impact of the programme: participation in fall prevention strategies and the factors influencing participation. (3) To identify the factors influencing RESPOND RCT outcomes: falls, fall injuries and emergency department (ED) re-presentations. Methods/design 528 community-dwelling adults aged 60-90 years presenting to two EDs with a fall will be recruited and randomly assigned to the intervention or standard care group. All RESPOND participants and RESPOND clinicians will be included in the evaluation. A mixed methods design will be used and a programme logic model will frame the evaluation. Data will be sourced from interviews, focus groups, questionnaires, clinician case notes, recruitment records, participant-completed calendars, hospital administrative datasets and audio-recordings of intervention contacts. Quantitative data will be analysed via descriptive and inferential statistics and qualitative data will be interpreted using thematic analysis. Discussion The RESPOND programme evaluation will provide information about contextual and influencing factors related to the RESPOND RCT outcomes. The results will assist researchers, clinicians and policy makers regarding decisions about future falls prevention interventions. Insights gained may be applicable to a range of chronic conditions where similar preventive intervention approaches are indicated. [ABSTRACT FROM AUTHOR]

Objective To explore experiences of cigar and cigarillo smokers under Australian laws requiring plain packaging (PP) and strengthened graphic health warnings (GHWs). Methods In February/March 2014, we conducted: in-depth interviews with 10 regular premium cigar smokers; two focus groups with occasional premium cigar and premium cigarillo smokers (n=14); four focus groups with non-premium cigarillo smokers (n=28); and a national online survey of cigar and/or cigarillo smokers (n=268). Results Premium cigar smokers had limited exposure to PP, with many purchasing fully branded cigars in boxes duty free or online and singles in non-compliant packaging. Those who were exposed noticed and were concerned by the warnings, tried to avoid them and felt more like 'dirty smokers'. Changes in perceived taste, harm and value were minimal for experienced premium cigar smokers. Occasional premium cigar and premium cigarillo smokers with higher PP exposure (gained by purchasing boxes rather than singles) perceived cigar/package appeal and value had declined and noticed the GHWs. Non-premium cigarillo smokers reported high PP exposure, reduced perceived appeal, quality, taste, enjoyment and value, somewhat increased perceived harm, greater noticeability of GHWs and concealment of packs and more contemplation of quitting. Online survey participants reported increased noticeability of GHWs (33%), decreased appeal of packaging (53%) and reduced consumption of cigars (42%) and cigarillos (44%) since PP implementation. Conclusions Non-premium cigarillo smokers appear to have been most exposed and influenced by PP, with cigar smokers less so, especially regular premium cigar smokers who have maintained access to fully branded products. [ABSTRACT FROM AUTHOR]